Internal Support Regulatory Writing

Criterion Edge can support your internal document writing requirements

Our team of regulatory writers and QC reviewers understand the workflow pressures within organizations, which are often the result of multiple or urgent requests for updates, amendments, new documentation practices or a lack of resources.

Let us help. Put our writers and support team to work on your internal writing needs. Listed here are just a few examples of the deliverables we can provide. Whatever your requirements and budget may be, Criterion Edge provides the capacity and flexibility to meet your needs.

Contact us for a free consult on your current needs.

Key Internal Support Deliverables include:

  • Protocols and Clinical Investigation Plans SOPs
  • Informed Consent Forms
  • Clinical Narratives
  • Evidence Gap Assessments
  • Briefing Documents
  • Working Group/KOL Advisory Board Summaries
  • Response Documents

[Ask the Expert] Safety and Performance Objectives and Acceptance Criteria for the PER

Join us for a LIVE Q&A session on January 26, 2022, at 11AM PST / 2PM EST with President Laurie Mitchell and Dr. Sarah Chavez. They will be answering questions regarding best methods and practices of identifying safety and performance measures and acceptance criteria for the performance evaluation report.

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.